An interventional study of CogmedRM and Mobymax in Neurofibromatosis Type 1, sponsored by Kristina Hardy. Completed at 1 site in United States. Open to participants aged 8 Years to 16 Years. Per ClinicalTrials.gov, last updated 2022-03-03.
Sponsored by Kristina Hardy · Not applicable, Interventional, and Treatment
The main objective of the study is to assess the efficacy of a home-based, computerized cognitive training (CT) program, called CogmedRM, targeted to improve working memory in children with NF1 and working memory difficulties. This is a Phase II randomized parallel group controlled clinical trial comparing two interventions on cognitive outcomes. Participants will be stratified by stimulant medication use and randomized equally between the two interventions within stratum. Participants will be in the study for to 11 weeks.
Cognitive deficits are the most important cause of long-term dysfunction in patients with Neurofibromatosis type 1 (NF1). Among the most frequently-occurring difficulties are problems with attention, working memory (WM), and executive functioning (EF). Remediation and interventions to improve those deficits have the potential to impact the quality of life and long-term prognosis in this population. Cognitive training (CT) programs have increasingly been used independently or in conjunction with pharmacotherapies in children with accidental or disease-related brain injury. CogmedRM is both the most well-researched and widely-used CT program for remediation of WM deficits. Results from numerous randomized, controlled trials conducted with a variety of pediatric and adult patient populations generally show that CogmedRM training is associated with robust gains in performance-based WM scores over the short term, with some variability in improvement across disease groups. A single arm pilot study of CogmedRM in a sample of children with NF1 conducted at Children's National Medical Center has shown that the approach is likely feasible and acceptable to families.
Because many children with NF1 are treated with stimulant medications, and there is biological evidence that both CT and Methylphenidate act on dopaminergic systems, the investigators are also interested in examining whether or not there is a synergistic effect between these widely available and safe interventions. Thus, the aim is to assess the efficacy of a home-based, computerized cognitive training (CT) program in a sample of 90 children aged 8-16 with NF1 and working memory difficulties. This study will be conducted over the span of four years. If the participant qualifies following baseline testing, he/she will be randomized to the intervention, CogmedRM, or the active control condition, MobyMax (an online reading program). The participant will have 5-9 weeks to complete the program and will have follow-up testing 2 weeks after finishing the program. If CT, either singly or in combination with stimulant medication, can be shown to be efficacious in a sample of NF1 pediatric patients at high risk for neurocognitive deficits, this intervention plan could be rapidly translated to clinical practice.
186 studies on the registry are indexed under Neurofibromatoses; 24 are open to participants now.
This study's enrollment of 103 is above the median of 26 across 120 interventional studies indexed under Neurofibromatoses.
Browse Neurofibromatoses studies →This is the only study on the registry with Kristina Hardy as lead sponsor.
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Exclusion Criteria:
Full scale IQ\<70, as estimated by WASI-II (Block Design, Vocabulary, Matrix Reasoning, Similarities).
Note: In cases where there is a statistically significant difference between verbal IQ and performance IQ (.05 level as determined by the WASI-II manual), participants will be eligible if at least one of these quotients is 70 or above
Cogmed RM is a computer program that consists of twelve visually-engaging and interesting exercises that target skills involving visuo-spatial and verbal Working Memory. During the intervention, children complete 25 training sessions. Children are asked to complete between 3 and 5 sessions per week, so the total treatment time to complete 25 sessions may range from 5 to 9 weeks. For children completing CogmedRM, sessions typically last between 25 and 45 minutes, depending on the child's working memory span.
Other: CogmedRM
MobyMax's "Reading Stories" program is a program that focuses on reading comprehension skills. Participants will start their training with stories that are matched to their reading "grade" level. Each grade contains 30 lessons, with 3 stories in each lesson. Participants are given questions to answer at the conclusion of each story, and children advance or remain at that level depending on the progression of their reading skill. Participants randomized to this program will be asked to train 30-45 minutes per session for 25 training sessions over a 5 to 9 week period.
Other: Mobymax
Cogmed RM is a computer program that consists of twelve visually-engaging and interesting exercises that target skills involving visuo-spatial and verbal Working Memory. Difficulty of the tasks is automatically adjusted on a trial-by-trial basis throughout each training session to match a child's current working memory span, such that as the child becomes more proficient, the exercises become more difficult. During the intervention, children complete 25 training sessions. Children are asked to complete between 3 and 5 sessions per week, so the total treatment time to complete 25 sessions may range from 5 to 9 weeks. For children completing CogmedRM, sessions typically last between 25 and 45 minutes, depending on the child's working memory span.
MobyMax's "Reading Stories" program is a program that focuses on reading comprehension skills. Participants will start their training with stories that are matched to their reading "grade" level. Each grade contains 30 lessons, with 3 stories in each lesson. Participants are given questions to answer at the conclusion of each story, and children advance or remain at that level depending on the progression of their reading skill. Participants randomized to this program will be asked to train 30-45 minutes per session for 25 training sessions over a 5 to 9 week period.
Change in CogState One-back subtest
Computerized task of working memory
Time frame: From baseline to end of training, up to 11 weeks
Change in Attention Deficit Hyperactive Disorder- Rating Scale
Parent-completed rating scale
Time frame: From baseline to end of training, up to 11 weeks
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Spatial Span Backward
Visual-spatial working memory task
Time frame: From baseline to end of training, up to 11 weeks
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Digit Span Backward
Auditory working memory task
Time frame: From baseline to end of training, up to 11 weeks
CogState One-card Learning
Computerized attention and executive functioning tasks
Time frame: From baseline to end of training, up to 11 weeks
Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Working Memory Index
Parent-completed questionnaire
Time frame: From baseline to end of training, up to 11 weeks
Change in Test of Word Reading Efficiency-Second Edition (TOWRE-2) Scores
Child-completed reading task
Time frame: From baseline to end of training, up to 11 weeks
Change in Test of Everyday Reading Comprehension (TERC) Scores
Child-completed reading task
Time frame: From baseline to end of training, up to 11 weeks
Change in Behavior Rating Inventory of Executive Functioning (BRIEF) Metacognition Index
Parent-completed questionnaire
Time frame: From baseline to end of training, up to 11 weeks
CogState Groton Maze Learning Task
Computerized task of executive functioning
Time frame: From baseline to end of training, up to 11 weeks
Change in Wechsler Intelligence Scale for Children-Fifth Edition-Integrated Letter-Number Sequencing
Auditory working memory task
Time frame: From baseline to end of training, up to 11 weeks
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